RecruitingNot Applicable

Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

United States175 participantsStarted 2024-09-12

Plain-language summary

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

Who can participate

Age range12 Years – 22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years * 2\) be between the ages of 12 and 22 years * 3\) in recognition of the heterogeneity of cSLE symptoms, have elevations in fatigue (i.e., T scores ≥60; or at least moderate symptoms, on the PROMIS measure) OR depressive symptoms (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), OR pain (i.e., average pain ≥3 out of 10 on the Pain VAS) * 4\) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll) * 5\) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver Exclusion Criteria: * 1\) other chronic medical conditions (e.g., juvenile arthritis) * 2\) a documented developmental delay, severe cognitive impairment, or thought disorder * 3\) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (PHQ9 score ≥21, BDI/CDI II \> 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)

What they're measuring

Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Fatigue, as measured by the PROMIS Fatigue short form (secondary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Pain, as measured by the Pain Visual Analog Scale (VAS)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Pain, as measured by PROMIS Pain Interference Short Form

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Psychological stress, as measured by the PROMIS psychological stress experience measure

Timeframe: T1 (baseline), T2 (8 weeks)

Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics

Trial details

NCT IDNCT06232304

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Jocelyn S Zuckerman, BA

9785051866 zucker32@msu.edu

View on ClinicalTrials.gov More Systemic Lupus Erythematosus of Childhood (Disorder) trials

Plain-language summary

Who can participate

Age range12 Years – 22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Fatigue, as measured by the PROMIS Fatigue short form (secondary)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Pain, as measured by the Pain Visual Analog Scale (VAS)

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Pain, as measured by PROMIS Pain Interference Short Form

Timeframe: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Psychological stress, as measured by the PROMIS psychological stress experience measure

Timeframe: T1 (baseline), T2 (8 weeks)

Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics